The SureWave Elastography device is intended for use with Siemens 1.5T and 3.0T MRI systems to generate shear wave vibrations in the body of adult patients during an MRI exam that are translated into images representing tissue stiffness. The images may be used for diagnostic purposes when interpreted by a trained physician.

Device Description

The SureWave Elastography device is an accessory to the MRI system comprised of both hardware and software components. The hardware induces shear wave vibrations in the body through a transducer which is driven by a mobile tower and two flexible rotating axes. The transducer is fastened to the patient's body and contains a rotatable eccentric mass which induces vibrations in the body during an MRI scan. The SureWave Elastography reconstruction software uses the acquired image data from the MRI system to create images that show tissue stiffness.

AI/ML Overview

The provided text describes the non-clinical and clinical tests performed to demonstrate the substantial equivalence of the SureWave Elastography device to its predicate devices. However, it does not explicitly define acceptance criteria in a table format with specific thresholds. It rather focuses on demonstrating similarity and accuracy to known values and predicate devices.

Based on the information provided, here's a structured response, with some sections noting what information is not present in the document.

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state acceptance criteria in a quantitative table format with predefined thresholds. However, the study aims to demonstrate accuracy and repeatability comparable to, or better than, the predicate device and known phantom values. The reported performance is summarized below:

Performance Metric	Implicit Acceptance Criteria (based on study design)	Reported Device Performance (SureWave 2D)	Reported Device Performance (SureWave 3D)	Notes/Comparison to Predicate
Accuracy (Phantom, kPa)	Values fall between predicate and expected values, and are comparable to expected values.	See table below.	See table below.	- SureWave Elastography 2D and 3D values fall between the predicate and expected stiffness values. - Computed stiffness values were "at least as accurate if not more accurate than the predicate method."
Specific Phantom Values:
Expected: 0.82 kPa	Close to 0.82 kPa	0.76 ± 0.01 kPa (95% CI)	0.73 ± 0.02 kPa (95% CI)
Expected: 2.02 kPa	Close to 2.02 kPa	2.53 ± 0.94 kPa (95% CI)	2.01 ± 0.07 kPa (95% CI)
Expected: 2.77 kPa	Close to 2.77 kPa	3.83 ± 0.44 kPa (95% CI)	3.27 ± 0.32 kPa (95% CI)
Expected: 5.80 kPa	Close to 5.80 kPa	5.80 ± 0.67 kPa (95% CI)	5.20 ± 0.09 kPa (95% CI)
Repeatability	Within 10% of the mean of the respective method, and comparable/better than predicate.	Within 10% of the mean.	Within 10% of the mean.	"Slightly better than that of the predicate."
Equivalency to Predicate (SureWave 2D)	Strong agreement with predicate, low bias.	Linear regression slope: 1.02 (R² = 0.99). Bland-Altman bias: 4%.	Not applicable.	"Excellent agreement," "no significant difference observed," "equivalent."
Equivalency to Predicate (SureWave 3D)	Strong linear relationship. Expected bias due to volumetric analysis.	Not applicable.	Linear regression R² = 0.99. Bland-Altman bias: approximately 20%.	"Strong linear relationship." Bias expected and potentially indicates more accuracy.

2. Sample sizes used for the test set and the data provenance

Accuracy Test (Phantom):
- Sample Size: Not explicitly stated as a "sample size" for a test set, but referred to as "MRE acquisitions from SureWave Elastography 2D, SureWave Elastography 3D, and the predicate MRE methods." The number of acquisitions per method for the general QA phantom repeatability testing was 240 measurements. It is implied similar extensive measurements were taken for the multi-component QA phantom.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective clinical data). The phantom study is a bench test, not human data.
Equivalency Test (Volunteer):
- Sample Size: 22 healthy adult volunteers.
- Data Provenance: Not explicitly stated (e.g., country of origin). The study involved "healthy adult volunteers," implying a prospective human study.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Phantom Studies: Ground truth for the phantom was established by the phantom manufacturer ("expected stiffness values established by the phantom manufacturer"). No human experts were involved in establishing this ground truth.
Volunteer Studies: For the healthy volunteer equivalency study, the "ground truth" was effectively established by the predicate device's measurements. The document states that the SureWave Elastography measurements were plotted against the predicate device to assess their relationship and bias. No independent expert consensus or interpretation was described as establishing a separate ground truth for this human volunteer data beyond the predicate device as the comparison standard.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

No adjudication method (e.g., expert consensus or multi-reader review beyond the device's output) is described for either the phantom or volunteer test sets. The focus appears to be on direct numerical comparison of the device's output against known phantom values or predicate device measurements.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study involving human readers and AI assistance is described. The study focuses on the device's performance in terms of stiffness measurement accuracy and repeatability, and its equivalence to a predicate device, not on diagnostic improvement for human readers. The device outputs images that are "interpreted by a trained physician," but the study does not evaluate this physician interpretation process.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Yes, the conducted tests, precisely the phantom and volunteer studies, evaluate the standalone performance of the SureWave Elastography device in generating stiffness measurements. The device produces quantitative stiffness values (kPa) and qualitative stiffness maps, confidence overlays, and wave images. The accuracy and repeatability of these outputs were directly assessed. While a trained physician interprets the images, the study's focus is on the device's ability to accurately produce those measurements, independent of a specific physician's interpretation improvement.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Phantom Studies: The ground truth was known physical properties of the phantom components, as provided by the phantom manufacturer.
Volunteer Studies: The ground truth for comparison was the measurements obtained from the legally marketed predicate device.

8. The sample size for the training set

The document does not provide information about a training set size. The described tests relate to the validation or verification of the device's performance, implying it has already been developed. As this is a 510(k) submission for a device that generates physical properties (stiffness) rather than AI-based diagnostic interpretations, it's possible a separate "training set" in the machine learning sense was not explicitly required or detailed in this summary.

9. How the ground truth for the training set was established

As no training set is described, information on how its ground truth was established is also not present in the document.

Summary

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February 12, 2025

Quality Electrodynamics, LLC Eric Yeh Senior Regulatory Affairs Specialist 6655 Beta Drive, Suite 100 Mayfield Village, Ohio 44143

Re: K242006

Trade/Device Name: SureWave Elastography (Q7000225) Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: December 27, 2024 Received: December 27, 2024

Dear Eric Yeh:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rue"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

D.K.

Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

Submission Number (if known)

K242006

Device Name

SureWave Elastography (Q7000225)

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary - SureWave Elastography

1. Contact Details

a. Applicant Name Quality Electrodynamics, LLC
b. Applicant Address 6655 Beta Drive, Suite 100 Mayfield Village, OH 44143
c. Applicant Contact Telephone 440-484-2940
d. Applicant Contact Mr. Eric Yeh
e. Applicant Contact Email eric.yeh@qualedyn.com

2. Device Name

a. Device Trade Name SureWave Elastography (Q7000225)
b. Common Name Magnetic resonance diagnostic device
c. Classification Name System, Nuclear Magnetic Resonance Imaging
d. Requlation Number 892.1000
e. Product Code(s) LNH

3. Legally Marketed Predicate Devices

a. K201389, Resoundant Acoustic Driver System, Product Code LNH
b. K140666, MR Elastography, Product Code LNH

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4. Device Description Summary

5. Intended Use/Indications for Use

6. Indications for Use Comparison

The Indications for Use statement for the SureWave Elastography is not identical to that of the predicate devices (Resoundant Acoustic Driver System and MR Elastography); however, the differences do not affect the safety or effectiveness of the device relative to the predicate devices. Both Indications for Use statements for the proposed SureWave Elastography and predicate Resoundant Acoustic Driver System indicate that the device is intended to be used in conjunction with a MR system to produce images representing tissue stiffness of the body anatomy and that the images can be interpreted by a trained physician. Furthermore, both apply MR acquisition sequence synchronized with an external source of vibration to produce said images representing tissue stiffness, and are both compatible with magnetic resonance diagnostic devices (MRDD) including MRI systems. The indications for use statements differ only in that the proposed SureWave Elastography has external source of vibration (shear waves) instead of acoustic vibration and achieves this via tower, transducer and axes instead of active driver, tubing and passive driver.

Technological Comparison 7.

At a high level, the proposed and predicate device are based on the following same technological elements:

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Intended to apply external source of vibration to produce images . representing tissue stiffness (in kiloPascals, kPa)
Applies MR acquisition sequence synchronized with an external source of vibration
. Compatible with magnetic resonance diagnostic devices (MRDD) including MRI systems
· Core images of stiffness maps, confidence overlay, and wave images are provided.

The following technological differences exist between the proposed and predicate device:

External source of vibration is shear waves (proposed device) versus ● acoustic vibration (predicate device 1)
. Tower, transducer and axes (proposed device) versus Active Driver, tubing and Passive Driver (predicate device 1)
Inversion algorithm offers 2D and 3D solutions (proposed device) . versus 2D solution only (predicate device 2)

Note that the hardware used in predicate 1 and predicate 2 are identical. Predicate 2 is included here because it also provides a software solution.

8. Non-Clinical and/or Clinical Tests Summary & Conclusions

Bench testing was completed to determine the repeatability and accuracy of the SureWave Elastography device compared to the predicate device.

MRE acquisitions from SureWave Elastography 2D, SureWave Elastography 3D, and the predicate MRE methods were compared against known stiffness values using a multi-component elasticity QA phantom containing three different elements with expected stiffness values established by the phantom manufacturer. Acquisitions were performed on a Siemens 3T system using sequences intended for use with each MRE method. Known stiffness values ranged from 2.02 to 5.8 kPa.

The results show that the stiffness values obtained with SureWave Elastography 2D and 3D methods fall between the stiffness values obtained from the predicate method and the expected stiffness value as determined

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by the QA elastography phantom manufacturer. Therefore, the computed stiffness values obtained from the SureWave Elastography methods were at least as accurate if not more accurate than the predicate method and the three methods can be considered equivalent.

SureWave Elastography 2D, SureWave Elastography 3D, and the predicate MRE methods were also used to acquire multiple repeated measurements using a general QA phantom to determine repeatability. 240 measurements were acquired from each method. The repeatability of all three methods was found to be within 10% of the mean of the respective method. Repeatability of the SureWave Elastography was slightly better than that of the predicate.

The data was combined to determine the expected accuracy of SureWave Elastography. Based on the data, see table below for expected accuracy of SureWave Elastography 2D and 3D.

Expected Value(kPa)	Measured Value (kPa)
	SureWave 2D*	SureWave 3D*
0.82	0.76 ± 0.01	0.73 ± 0.02
2.02	2.53 ± 0.94	2.01 ± 0.07
2.77	3.83 ± 0.44	3.27 ± 0.32
5.80	5.80 ± 0.67	5.20 ± 0.09

95% confidence interval

Equivalency of SureWave Elastography results compared to the predicate device was verified through volunteer testing. SureWave Elastography 2D and 3D as well as the predicate device were used to collect images and stiffness measurements from a total of 22 healthy adult volunteers. The stiffness measurements obtained from the SureWave Elastography 2D and 3D were separately plotted against the predicate device. Linear regression was then applied to assess the relationship between the two methods and Bland-Altman plots were used to evaluate the bias between the two methods.

The SureWave Elastography 2D versus the predicate device plot showed excellent agreement between the two methods. The linear regression had a slope of 1.02 (R2 = 0.99) and the Bland-Altman plot showed a bias of 4%. Therefore, no significant difference was observed between SureWave Elastography 2D and the predicate device; the two methods are equivalent.

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The linear regression of SureWave Elastography 3D versus the predicate device showed a strong linear relationship (R2 = 0.99) between the SureWave Elastography 3D technique and the predicate device. The linear regression slope and Bland-Altman plots indicated a bias of approximately 20% between the two methods. The 3D image uses volumetric analysis instead of the 2D single slice analysis, therefore, a bias in stiffness measurements between 2D to 3D was expected. The non-clinical testing and literature indicates that the 3D measurements may actually be more accurate than the 2D measurements.

The electrical safety and electromagnetic compatibility and biocompatibility data support the safety of the SureWave Elastography. The bench and clinical testing show that SureWave Elastography produces highly reproducible stiffness measurements consistent with those obtained from the predicate device and industry standard. This testing demonstrates that the SureWave Elastography is substantially equivalent to the predicate device.

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.